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RTF Template

State Medicines Control Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	0479
2. Name of Authorisation Holder	:	UAB "Novo Nordisk Pharma"
3. Address(es) of Site(s)	:	J. Jasinskio g. 16B, Vilnius, LT-03163, Lithuania

4. Legally registered address of Authorisation Holder	:	J. Jasinskio g. 16B, Vilniaus m., Vilniaus m. sav., LT-03163
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2005-11-17
10. Annexes attached	:	Annex 1 Scope of wholesale distribution authorisation Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number Annex 3 (Optional) Name(s) of responsible person(s) Annex 4 (Optional) Date of Inspection on which authorisation was granted Annex 5 (Optional) Additional provisions based on national requirements

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: UAB "Novo Nordisk Pharma"

, J. Jasinskio g. 16B, Vilnius, LT-03163, Lithuania

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Biotechnological medicinal products. Biotechnologiniai vaistiniai preparatai

Any restrictions or clarifying remarks (for all users): Agreement No. S06-331 of 1 January 2016 with UAB "Tamro", Gamybos g. 4, Ramučių k., Karmėlavos sen., Kauno r. sav., Lithuania (Wholesale distribution authorisation No. 0057). Wholesale distribution operations performed according to the agreement: reception, holding (warehousing), collection and transportation of medicinal products.

2016-01-01 sutartis Nr. S06-331 su UAB "Tamro", Gamybos g. 4, Ramučių k., Karmėlavos sen., Kauno r. sav. (Didmeninio platinimo licencija Nr. 0057). Pagal sutartį vykdomi didmeninio platinimo veiksmai: vaistinių preparatų priėmimas, laikymas (saugojimas), surinkimas ir transportavimas.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Union Format for a Wholesale Distribution Authorisation	0479
	Page 1

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